CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency

(RTTNews) - Swiss pharma firm CSL Vifor, a subsidiary of Australia's CSL Ltd. (CSL.AX, CSLLY.PK), announced Monday that the U.S. Food and Drug Administration (FDA) has granted its partner American Regent, Inc., a Daiichi Sankyo Group company, approval for Injectafer for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

CSL Vifor has granted American Regent an exclusive right to develop, manufacture and market Injectafer in the United States.

The FDA approval was supported by CSL Vifor's randomized placebo-controlled study, CONFIRM-HF (NCT01453608), which evaluated the efficacy and safety of ferric carboxymaltose in adult patients with symptomatic heart failure and iron deficiency.

The treatment over a 1-year period resulted in a significant and sustainable improvement in exercise capacity in this patient population.